BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE BICLAMP LAPAROSCOPIC FENESTRATED INSERT

    MDR report key: 15690775 · Received October 28, 2022

    Report

    Report Number
    9610614-2022-00039
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 12, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K033421
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BICLAMP LAPAROSCOPIC INSTRUMENT (INCLUDING THE INSERT) WAS INSPECTED/TESTED. THE DEVICE HAD SIGNS OF EXCESSIVE WEAR AND THE COATING ON THE BRANCHES WAS DAMAGED. THE SPOT WELD WAS PRESENT BUT NOT INTACT AT THE FASTENING SCREW LOCATION. IT APPEARS THAT THE DAMAGED SPOT WELD WAS CAUSED BY A MECHANICAL STRESS (E.G., LEVERING OR TORSION) RESULTING FROM AN UNINTENDED USE OF THE DEVICE. HOWEVER, THE EXACT CAUSE OF THE WELD AND SCREW COMING APART IS UNKNOWN. IN THE DEVICE'S NOTES ON USE, IT IS STATED THAT NO EXCESSIVE LEVERING OR EXERTING EXCESSIVE FORCES ON THE INSTRUMENT MUST BE DONE, THE PRODUCT MUST BE CHECKED FOR DAMAGE BEFORE EACH USE. DAMAGED/WORN OUT INSTRUMENTS MUST NOT BE USED. NO TRENDS HAVE BEEN IDENTIFIED. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE BICLAMP LAPAROSCOPIC INSTRUMENT DURING A LAPARASCOPY (NOTE: THE INFORMATION REGARDING THE SPECIFIC PROCEDURE WAS NOT PROVIDED.). THE ACCESSORY WAS BEING USED WITH AN ELECTROSURGICAL UNIT (ESU). SPECIFIC INFORMATION REGARDING THE ESU, SETTINGS, AND OTHER DEVICES USED WAS NOT PROVIDED. DURING THE PROCEDURE, THE FASTENING SCREW IN THE JOINT AREA BECAME DETACHED FROM THE BICLAMP LAPAROSCOPIC FENESTRATED INSERT. AS A RESULT, THE INSTRUMENT'S JAWS COULD NO LONGER BE CLOSED; THEREFORE, THE INSTRUMENT WAS REMOVED FROM THE SITE TOGETHER WITH THE TROCAR WITH THE BRANCHES OPEN. AN EXAMINATION OF THE DEVICE SHOWED THAT THE SMALL FASTENING SCREW IN THE AREA OF THE JOINT OF THE BRANCHES WAS MISSING. THE SCREW COULD NOT BE DETECTED BY X-RAY DIAGNOSTICS. AT THIS TIME, THE WHEREABOUTS OF THE SCREW IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS WITH ANY ADDITIONAL INTERVENTIONAL WORK DONE OR PLANNED BY MEDICAL PROFESSIONALS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704091 ERBE BICLAMP LAPAROSCOPIC FENESTRATED INSERT BIPOLAR ESU LAPAROSCOPIC INSTRUMENT GEI ERBE ELEKTROMEDIZIN GMBH 701542

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female